Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency

Abstract

Real world data (RWD) usually refers to healthcare information that is routinely collected in electronic healthcare records (EHR), hospital and pharmacy records, patient and disease registries, and health insurance databases. The collection and analysis of this vast amount of data is an important complement to that obtained from conventional randomised controlled trials (RCT). RWD has been used for healthcare quality improvements, to conduct clinical trials, to support drug and device development, and to inform medical guidelines. The utility of RWD is facilitated by common data models, which standardise format and content, and allow data from different health systems to be analysed together. The European Society of Cardiology (ESC) supports the use of RWD in collaboration with national cardiac societies, regulatory authorities and industry to encourage continuous quality of care improvements at the hospital and country level, to conduct registry-based randomised clinical trials (R-RCT) and to facilitate safety surveillance of novel drugs and devices. The European Medicines Agency (EMA) is developing systems and processes to enable the use of RWD that can help in trial planning, defining clinical contexts, and enhancing outcome assessments. RWD can also contribute to the measurement of the impact of regulatory actions, such as contraindications or restriction of indications by looking at medicines use patterns over time across European Member States. A number of other initiatives from the European Commission and the EMA are underway to strengthen the EU's health security framework, and foster the collection and utilisation of RWD.

A blueprint for success in real-world evidence: “glocal” approach to building capabilities and generating impactful evidence

“…Real World Evidence (RWE) can be used to improve quality of care and clinical outcomes by providing a more comprehensive understanding of the effectiveness and safety of therapies ( Szymański et al, 2023 ). As a result, RWE is now considered an additional important source for decision making across Healthcare, Health Authorities, Payers, and Pharmaceutical Industries ( Food and Drug Administration, 2018 ; Facey et al, 2020 ; Rudrapatna and Butte, 2020 ).…”